ethics & medical research sharing the experience
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Ethics & Medical Research Sharing the experience. R.K. Baxi Professor Medical College, Baroda. Ensure Purpose of research is towards betterment of all Research is conducted with professional fair treatment and transparency Evaluation at all stages of proposal – - PowerPoint PPT PresentationTRANSCRIPT
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R.K. BaxiProfessor
Medical College, Baroda
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Ensure
Purpose of research is towards
betterment
of all
Research is conducted with
professional
fair treatment and transparency
Evaluation at all stages of proposal –
research design
declaration of results
use of results
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1. Essentiality
2. Voluntariness, informed consent
and community agreement
3. Non-exploitation
4. Privacy and confidentiality
5. Precaution and risk minimization
6. Professional competence
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7. Accountability and
transparency
8. Maximization of the public
interest
9. Institutional arrangements
10.Public domain
11.Totality of responsibility
12.Compliance
12 PRINCIPLES OF ETHICS IN 12 PRINCIPLES OF ETHICS IN MEDICAL RESEARCH MEDICAL RESEARCH (Declaration of Helsinki)(Declaration of Helsinki)
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HIV related research has brought to focus many issues related to Ethics as now we know that HIV is not Bio-medical alone
HIV necessitated robust socio-behavioral research
HIV research brought to fore the issues related to stigma, disclosure, power equations between providers and clients
Pandemic is also moving from “only high risk behaviour groups” to general population, hence more diverse and complex
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Vulnerability to HIV is also beyond physiological reasons
Though virus does not discriminate per se, pattern of HIV infection as a public health problem does show powerful influence of socio-cultural, economic and related behavioral factors
Hence, Ethical considerations also will have to be embedded into socio-cultural realities
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Ethics in Indian research scenario is guided by ICMR, statement of General Principles on ethical considerations
Most of which, as we all know, is in line with International Guidelines and Principles
These guidelines have precious little specifics on socio-behavioural research, which is so important to HIV related research, however, at places within the document, it expects researchers to be sensitive to the local cultural context
Ethics in Indian Research
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Availability of ART and rapid expansion of ART services open up several other issues related to Ethics:
Equal opportunity to access and availability Ability to pay for the same Priority treatment to vulnerable groups At times, populations studied are NOT the ones who are beneficiaries! Gender based disadvantage Issues related to consent for treatment of adolescents/children are some other issues with NO final answer.
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NACO Ethical Guidelines for Operational research on HIV/AIDS(2008) is another set of guidelines which help.
This particular guideline is more explicit on issues like anonymity, confidentiality, patient information, partner notification and compensation
Social context of clinical /biomedical intervention is now more in focus as eventual impact favorable or otherwise depends a lot on the same.
NACO Ethical Guidelines
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Social science research should be relevant to the community and be beneficial to marginalized, vulnerable.
Selection of respondents should not mean targeting or stigmatizing
Given the cultural and social diversity, generalisability of research findings may be done carefully, giving due weightage to the “outliers”
Hope, someday ,we would afford the luxury of individual, issue-based counseling..
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Issues and problems
Independence and Competence: Are our Institutional Ethics Committee (IEC) independent and competent?
Do we have a proper constitution of the same?
Are members trained in Ethics/GCP?
Are there SoPs for the conduct of IEC?
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Issues and problems
Do we perceive the need to have separate technical/scientific review from the Ethical review?
Do members have adequate time for this serious business? Are they adequately compensated?
A lot remains to be done………
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Dilemma… Disclosure of status to wife/husband Disclosure at workplace Why not disclose to school authority? Counselors and Out reach workers not maintaining confidentiality Compensation to whom? How much is the right compensation? How about the human rights of the health care providers in face of general non-availability of Universal precautions? Knowing the status, disclosure, loss of confidentiality and its impact on sexual behaviour
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